Compares a wristband blood pressure device with 24-hour monitoring in young people
Compares a cuffless wristband with 24-hour blood pressure monitoring in young people.
Plain-language title generated from the registry record
Registry title: A Multi-centre Study Evaluating the Performance and Acceptance of the Hilo Band Cuffless Blood Pressure Medical Device in the Normo-, Hypo- and Hyper-tensive Young Population: a Comparison With the 24-h Ambulatory Blood Pressure Monitoring (ABPM)
Key facts
- Where
- Bellinzona and Geneva, SwitzerlandSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 35 years old?
Source: NCT07072689, who can take part
Where in Switzerland
- Ente Ospedaliero CantonaleBellinzona, SwitzerlandTaking people
- Geneva University Hospitals-HugGeneva, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Simonetti Giacomo
- Trial code
- NCT07072689
- Record updated
- 13 October 2026
- Original description
Hypertension is one of the main risk factors for the onset of cardiovascular diseases. It is often silent, and most individuals are unaware they have it.Read full original descriptionShow less
A Multi-centre Study Evaluating the Performance and Acceptance of the Hilo Band Cuffless Blood Pressure Medical Device in the Normo-, Hypo- and Hyper-tensive Young Population: a Comparison With the 24-h Ambulatory Blood Pressure Monitoring (ABPM)
Hypertension is one of the main risk factors for the onset of cardiovascular diseases. It is often silent, and most individuals are unaware they have it.
The 24-hour Ambulatory Blood Pressure Monitoring (24-hour ABPM) device allows for continuous blood pressure (BP) monitoring over a 24-hour period and is currently considered the gold standard for diagnosing hypertension. However, it is expensive, time-consuming for healthcare personnel, bulky, and often uncomfortable to wear-especially during the night.
Recently, other BP monitoring devices have entered the market. One of them is the Aktiia bracelet, renamed as Hilo band as of 8 april 2025, (Hilo band SA, Neuchâtel, Switzerland), CE-marked, which estimates BP and heart rate using a pulse wave analysis (PWA) technique. Hilo band is non-invasive, comfortable to wear, and allows for long-term BP monitoring.
Especially in adolescents, BP monitoring might present a special challenge due to high physical activity and often low compliance. Wearable technologies like Hilo band could offer an interesting alternative to the traditional 24-h ABPM. Results in young active adults and adolescents might be different comparing between Hilo and the 24-h ABPM and need to be assessed.
Furthermore, adolescents often dislike the 24-h ABPM beacuse of the discomfortable BP cuff (specially during the night) and the stigmatic effect of the 24-h ABPM at school/work.
To conclude, there is a need especially in young people of comfortable, precise and user-friendly technique for long term BP measurement and monitoring.
However, there is insufficient data to support the use of Hilo band in healthcare settings for the diagnosis and monitoring of hypertension. In one study, Hilo band was compared to the 24-hour ABPM only for daytime BP readings in a population enrolled in a cardiac rehabilitation program, and thus was not tested in apparently 'healthy' individuals who may be hypertensive. Another study assessed Hilo band's performance compared to double auscultation in older adults aged 65 to 85 years in different body positions (sitting, standing, and lying down); therefore the young population and adolescents were not considered.
In our research project, we aim to evaluate the performance of Hilo band compared to 24-hour ABPM in a young population (including adolescents), considering both daytime and nighttime blood pressure measurements.
Inclusion: Population 1:; Informed Consent signed by the subject/legal representative; 14-20 years of age; Clinical indication to receive a 24-h ABPM measurement; Functional internet phone connection; Negative pregnancy test, ongoing anti-conceptive treatment or declaration of the subject not being pregnant; Population 2:; Informed Consent signed by the subject; 21-35 years of age; Clinical indication for receiving a 24-hour blood pressure measurement; Functional internet phone connection; Negative pregnancy test, ongoing anti-conceptive treatment or declaration of the subject not being pregnant; Population 3; Informed Consent signed by the subject; 21-35 years of age; Functional internet phone connection; Negative pregnancy test, ongoing anti-conceptive treatment or declaration of the subject not being pregnant.
Exclusion: Allergies to silicone; Subjects with arrhythmia; Exfoliative skin diseases and lymphoedema or damaged/injured skin at the wrist; Individuals with lack of judgment/mental illness; Pica disorder; Patients suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL / min / 1.73 m2), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula; Atrial fibrillation; Interarm Systolic Blood Pressure (SBP) difference over 10% or Diastolic Blood Pressure (DBP) difference over 10%; Arm paralysis; Amputated upper limb; Arm trembling or shivering; Upper arm circumference > 64 cm; Wrist circumference > 22 cm; Pregnant women; Sleepwalking and severe insomnia.